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Ultraviolet Sun Tanning Unit Kettler Holiday Solar

by Mottek Intl. Corp.

510(k) K855162

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK855162 Date12 Feb 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTC
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultraviolet Sun Tanning Unit Kettler Holiday Solar Model 7500/000 is a dermatological ultraviolet light device designed for artificial tanning. Classified under the FDA’s Light, Ultraviolet, Dermatological category, it emits ultraviolet radiation to simulate sun exposure and induce skin pigmentation.

This device is intended for use in professional tanning facilities and has received FDA 510(k) clearance under product code FTC. It is classified as a Class II medical device and is regulated under FDA regulation number 878.4630. The unit is not described as single-use or reusable in the available data, and no specific sterility or MRI safety information is provided.

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